Breast CancerPhase 2NCT01230970
Exploratory Study to Assess the Short Term Intratumoural and Peripheral Effects of BN83495 in Postmenopausal Women With Newly Diagnosed Breast Cancer
A Phase 2 study testing BN83495 in people with Breast Cancer, run by Ipsen at 1 site in Norway.
Trial summary
This trial will assess the intratumoural pharmacological activity of BN83495 by changes in intratumoural levels of sex hormones and associated inhibition of steroid sulphatase (STS) activity. Read more about this study
- Who is it for?
- Ages 55 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- BN83495
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteNorway
- Study dates
- May 2011to May 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects 55 to 80 years with histologically or cytologically documented primary intraductal or lobular invasive breast cancer that meets the following criteria:
- T2, N0 or N1, M0.
- Primary tumour clinically determined to be 2 to 5 cm in the greatest dimension.
- Laboratory documentation of positive oestrogen receptor (ER+) status in at least 10% of the tumour cells.
- Laboratory documentation of HER-2 negative status.
- Postmenopausal defined as
Show all 10Show fewer
- no spontaneous menses for a total of 2 years
- amenorrheic for at least 12 months with serum oestrogen level <30 pg/mL, and both luteinising hormone (LH)/follicle stimulating hormone (FSH) >20 IU/L, chemotherapy-induced amenorrhoea for at least 12 months
- bilateral oophorectomy, or radiation castration and amenorrhoeic for at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Who cannot join
- Has locally advanced breast cancer that is considered non-operable without neoadjuvant therapy.
- Has evidence of metastatic disease
- as a diagnosis of inflammatory breast cancer
- Has ductal carcinoma in situ
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Open-label, Exploratory Study to Assess the Short Term Intratumoural and Peripheral Effects of BN83495 Administered for 14 Days Prior to Surgery to Postmenopausal Women With Newly Diagnosed Primary Invasive Oestrogen Receptor Positive Breast Cancer
This trial will assess the intratumoural pharmacological activity of BN83495 by changes in intratumoural levels of sex hormones and associated inhibition of steroid sulphatase (STS) activity.
- Conditions
- Breast Cancer
- Being tested
- BN83495
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BN83495Drug
40mg tablet oral daily administration from Day 1 to Day 14.
| Study group | Role | What they receive |
|---|---|---|
| BN83495 | Experimental | 40mg tablet oral daily administration from Day 1 to Day 14. Receives: Drug: BN83495 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intratumoural levels of sex hormones
Measured: Baseline and Day 14
Intratumoural steroid sulphatase activity
Measured: Baseline and Day 14
Secondary outcomes (6)
Change in the intratumoural Ki67 proliferation index
Measured: Baseline and Day 14
Proportion of subjects with a decrease in Ki67 staining ≥50%
Measured: Baseline and Day 14
Proportion of subjects with complete cell cycle response, defined as Ki67 staining ≤1%
Measured: Baseline and Day 14
Change in Apoptotic Index determined by M30 antibody
Measured: Baseline and Day 14
Change in Growth Index (Ki67 proliferation index/M30 apoptotic index)
Measured: Baseline and Day 14
Change in steroid sulphatase activity in peripheral blood mononuclear cells (PBMCs).
Measured: Baseline and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startMay 2011
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: The futility analysis of study NCT00910091 in patients with endometrial cancer shows that the primary endpoint will not be reached.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230970
- Sponsor's protocol ID
- X-55-58064-005
- Status last verified
- Jan 2019
- First submitted
- 20 Oct 2010
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Exploratory Study to Assess the Short Term Intratumoural and Peripheral Effects of BN83495 Administered for 14 Days Prior to Surgery to Postmenopausal Women With Newly Diagnosed Primary Invasive Oestrogen Receptor Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT01230970
- Acronym / sponsor ID
- X-55-58064-005
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The futility analysis of study NCT00910091 in patients with endometrial cancer shows that the primary endpoint will not be reached.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 29 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will assess the intratumoural pharmacological activity of BN83495 by changes in intratumoural levels of sex hormones and associated inhibition of steroid sulphatase (STS) activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BN83495 | Experimental | Drug: BN8349540mg tablet oral daily administration from Day 1 to Day 14. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female subjects 55 to 80 years with histologically or cytologically documented primary intraductal or lobular invasive breast cancer that meets the following criteria:
- T2, N0 or N1, M0.
- Primary tumour clinically determined to be 2 to 5 cm in the greatest dimension.
- Laboratory documentation of positive oestrogen receptor (ER+) status in at least 10% of the tumour cells.
- Laboratory documentation of HER-2 negative status.
Key exclusion criteria (4 listed)
- Has locally advanced breast cancer that is considered non-operable without neoadjuvant therapy.
- Has evidence of metastatic disease
- as a diagnosis of inflammatory breast cancer
- Has ductal carcinoma in situ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BN8349540mg tablet oral daily administration from Day 1 to Day 14. | Drug | BN83495 |
Primary outcome
Intratumoural levels of sex hormones
Time frame: Baseline and Day 14
Intratumoural steroid sulphatase activity
Time frame: Baseline and Day 14
6 secondary outcomes
Change in the intratumoural Ki67 proliferation index
Time frame: Baseline and Day 14
Proportion of subjects with a decrease in Ki67 staining ≥50%
Time frame: Baseline and Day 14
Proportion of subjects with complete cell cycle response, defined as Ki67 staining ≤1%
Time frame: Baseline and Day 14
Change in Apoptotic Index determined by M30 antibody
Time frame: Baseline and Day 14
Change in Growth Index (Ki67 proliferation index/M30 apoptotic index)
Time frame: Baseline and Day 14
Change in steroid sulphatase activity in peripheral blood mononuclear cells (PBMCs).
Time frame: Baseline and Day 14
Results and safety
The study was stopped early (reason given: The futility analysis of study NCT00910091 in patients with endometrial cancer shows that the primary endpoint will not be reached.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
Related trials for Breast Cancer
Active, not recruiting
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Bone Metastases, HER2-positive Breast Cancer
Active, not recruitingObservational study
A ReaL World Study of DS-8201
Breast Cancer Metastatic, Treatment Efficacy
RecruitingPhase 3
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Breast Neoplasms
RecruitingObservational study
Characterization of Extracellular Vesicles in Breast Cancer Patients
Breast Cancer
Not yet recruitingPhase 4
Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant Setting
Hormone Therapy-induced Arthralgia, Phytotherapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BN83495 in people with Breast Cancer, run by Ipsen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The futility analysis of study NCT00910091 in patients with endometrial cancer shows that the primary endpoint will not be reached.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intratumoural levels of sex hormones (time frame: Baseline and Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.